The MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only.

The MS System (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. MS System (Narrow Ridge) is intended for single use only. It is not for immediate load.

Device Description

The MS System is a dental implant made of Ti-6Al-4V metal. The MS System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface treatment of MS System is R.B.M (Resorbable Blasting Media).

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets them in the format requested.

The document is a 510(k) Summary for a dental implant system (MS System) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing specific performance acceptance criteria and a study to meet them.

Here's a breakdown of what is and is not in the provided text:

What is present:

Device Name: MS System Dental Implant
Intended Use: The text describes the intended use for two versions: MS System (Denture) and MS System (Narrow Ridge).
Material: Ti-6Al-4V metal.
Surface Treatment: R.B.M (Resorbable Blasting Media).
Biocompatibility: Mentions biocompatibility tests were performed.
Predicate Devices: K072959 (MS System (Denture)), K080594 (MS System (Narrow Ridge)), and K080129 (Secure Implant System).

What is NOT present in the provided text:

A table of acceptance criteria and reported device performance: This document states that "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations" and that the "MS System has been subjected to safety, performance, and product validations prior to release." However, it does not provide specific quantitative acceptance criteria or the actual performance results against those criteria.
Sample size used for the test set and data provenance: No information about a specific test set, its size, or where the data came from (country, retrospective/prospective).
Number of experts and qualifications for ground truth: No mention of experts or their role in establishing ground truth for any test.
Adjudication method for the test set: Not applicable as no test set with expert ground truth is described.
Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study would compare human reader performance with and without AI. Since the device is a dental implant, not an AI diagnostic tool, an MRMC study is not relevant and not mentioned.
Standalone (algorithm only) performance: Not applicable as this is a physical medical device.
Type of ground truth used: Not applicable as no specific performance study with ground truth is described.
Sample size for the training set: Not applicable as this is a physical medical device, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

The document concludes that the MS System is "safe and effective and substantially equivalent to the predicate device." This substantial equivalence is based on similar material, indication for use, design, and technological characteristics, as well as general safety and biocompatibility tests, but not a detailed performance study against specific acceptance criteria as you would typically see for a new diagnostic device or AI algorithm.

Summary

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K08 3067

FEB - 2 2009

Image /page/0/Picture/2 description: The image shows the logo for OSSTEM. The logo consists of a circular graphic above the word "OSSTEM". The circular graphic is made up of several concentric circles that appear to be slightly distorted, giving it a dynamic, swirling appearance.

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: September 30, 2008

Company and Correspondent making the submission:

Submitter's Name :

OSSTEM Implant Co., Ltd.

Mr. JongHyuk Seo

Address :

#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea

Contact :

Device :

Trade or (Proprietary) Name : Common or usual name :

Classification Name :

MS System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

Predicate Device :

MS System (Denture), OSSTEM Implant Co., Ltd. (K072959) MS System (Narrow Ridge), OSSTEM Implant Co., Ltd. (K080594)

Description :

The MS System is substantially equivalent in design, function and intended use to the MS System (Denture) and MS System (Narrow Ridge) of OSSTEM Implant Co., Ltd, (K072959, K080594)

Indication for use :

QS-QI-505-1(Rev.0)

Letter(8.5 X 11in)

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osstem

OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel. +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

1. Review :
  The MS System has similar material, indication for use, design and technological characteristics as the predicate device.

The MS System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

7. Conclusion :

Based on the information provided in this premarket notification Osstem concludes that the MS System is safe and effective and substantially equivalent to the predicate device as described herein

QS-QI-505-1(Rev.0)

Letter(8.5 X 11in)

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Image /page/2/Picture/0 description: The image shows the logo for Osstem. The logo consists of a circular design made up of three curved lines that appear to be intertwined. Below the circular design, the word "osstem" is written in a lowercase sans-serif font.

SSTEM Implant Co., Ltd.

OSSTEM Implant Co., Ltd.
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstein.com

■ Predicate Devices

	MS System(Narrow Ridge)	MS System (Denture)	Secure Implant System
510K	K080594	K072959	K080129
Design	Image: MS System (Narrow Ridge)	Image: MS System (Denture)	Image: Secure Implant System
IntendedUse	The MS System (NarrowRidge) is intended to use in thetreatment of missingmandibular central and lateralincisors to support prostheticdevice, such as artificial teeth,in order to restore chewingfunction in partially edentulouspatients. MS System (NarrowRidge) is intended for singleuse only. It is not for immediateload.	The MS System (Denture) isintended to be place in the boneof the upper or lower jawarches to provide support theprosthetic devices to restore thepatient's chewing function,including the denturestabilization. MS System(Denture) is intended for singleuse only.	Secure Implant System(2.5/3.0mm) is designed foruse in dental implant surgeryand is intended for use in amanner in which the implantsintegrate with the bone(osseointegration). It isintended to provide immediatetransitional splinting stabilityor intrabony long-termfixation of new or existingcrown, bridge and dentureinstallations in partially orfully edentulous patients.
BodyDiameter(D)	3.0	2.0~3.0	2.5, 3.0
Length(mm)	10.0, 13.0, 15.0	10.0, 13.0, 15.0	10.0, 12.0, 14.0, 16.0
Surface	RBM	RBM	RBM
Material	Titanium alloy Ti-6Al-4V(ASTM F 136-02A)	Titanium alloy Ti-6Al-4V(ASTM F 136-02A)	Titanium alloy Ti-6Al-4V(ASTM F 136-02A)
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile

QS-QI-505-1(Rev.0)

Letter(8.5 X 11in)

・

•

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and is smaller than the eagle symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 2009

Osstem Implant Company, Limited C/O Mr. MinJoo Kim Manager Hiossen, Incorporated 85 Ben Fairless Drive Fairless, Pennsylvania 19030

Re: K083067

Trade/Device Name: MS System Regulation Number: 872.3640 Regulation Name: Endosseous Dental implant Regulatory Class: II Product Code: DZE Dated: January 7, 2009 Received: January 12, 2009

Dear Mr. Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony D. Watson for
Ginette Y. Michaud, M.D.

Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the Osstem logo. The logo consists of a circular graphic above the word "osstem". The circular graphic appears to be a stylized representation of a tooth or dental implant. The word "osstem" is written in a simple, sans-serif font.

510(k) Number K _

Device Name: MS System

Indication for use : The MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only.

The MS System (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. MS System (Narrow Ridge) is intended for single use only. It is not for immediate loading.

Prescription Use X (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Reaser

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Letter(8.5 X 11in)

QS-QI-505-1(Rev.0)

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.